[guest post by Dana]
[Ed. Since we’ve been discussing chloroquine phosphate and hydroxychloroquine, consider this a thread related to treatments being considered (including testing a coronavirus vaccine). Also, in light of this weekend’s comments, please remember this isn’t a place to “promote” a specific treatment...]
The U.S. Department of Health and Human Services (HHS) today accepted 30 million doses of hydroxychloroquine sulfate donated by Sandoz, the Novartis generics and biosimilars division, and one million doses of chloroquine phosphate donated by Bayer Pharmaceuticals, for possible use in treating patients hospitalized with COVID-19 or for use in clinical trials. These and other companies may donate additional doses, and companies have ramped up production to provide additional supplies of the medication to the commercial market.
The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to BARDA to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible.
Sandoz and Bayer are the latest companies stepping up to strengthen the U.S. response to COVID-19, and ASPR is working with additional companies willing to donate doses of hydroxychloroquine and chloroquine…
Use of the donated medications is expected to help ease supply pressures for the drug, and the FDA is also working with manufacturers of chloroquine and hydroxychloroquine to increase production to ensure these drugs also remain available for patients dependent on them for treatment of malaria, lupus and rheumatoid arthritis. Some states and retail pharmacies also have taken action to preserve the supply of these and other drugs for these patients.
In addition to accepting and distributing the donated medicines, HHS is funding clinical trials of two drugs, Kevzara (sarilumab) and remdesivir, and is supporting the earlier development of multiple potential therapeutic treatments, vaccines, and diagnostic tests for COVID-19.
Time is not your friend during a pandemic. Doctors in France and Italy are already prescribing hydroxychloroquine and chloroquine as treatments for coronavirus patients.
Johnson & Johnson said Monday human testing of its experimental vaccine for the coronavirus will begin by September and it could be available for emergency use authorization in early 2021.
J&J also said it has committed more than $1 billion of investment in partnership with the federal Biomedical Advanced Research and Development Authority, which is part of the Department of Health and Human Services, to co-fund vaccine research.
J&J’s lead vaccine candidate will enter a phase 1 human clinical study by September, the company said, and clinical data on its effects is expected before the end of the year. If the vaccine works well, the company said it could be available for emergency use in early 2021.
On top of a lead vaccine candidate, J&J said it has two back-ups. The company said it began working on COVID-19 vaccine development in January.